Hypomethylating Therapy With or Without Eltrombopag in Elderly Patients With Acute Myeloid Leukemia: Results From the Randomized, Placebo-Controlled Phase 2 DELTA Trial

Katja Sockel¹, Christoph Röllig¹, Anke Mütherig¹, Martina Crysandt^{2

3}, Sven Zukunft¹, Regina Herbst⁴, Richard Noppeney⁵, Kerstin Schäfer-Eckardt⁶, Martin Kaufmann⁷, Uta Oelschlaegel¹, Frank Fiebig¹, Aristoteles Giagounides⁸, Katharina Götze⁹, Sebastian Scholl¹⁰, Andreas Lück¹¹, Kathrin Rieger¹², Thomas Geer¹³, Philipp Kiewe¹⁴, Carsten Müller-Tidow^{15

16}, Hubert Serve^{17

18

19}, Claudia D Baldus²⁰, Ulrich Kaiser²¹, Stefan Mahlmann²², Burkhard Schmidt²³, Stefani Parmentier²⁴, Thomas Illmer²⁵, Ruth Seggewiss-Bernhardt²⁶, Alexander Kiani²⁷, Hartmut Linde²⁸, Heinz Dürk²⁹, Michael Kramer³⁰, Desiree Kunadt¹, Katharina Schmidt-Brücken¹, Ekaterina Balaian¹, Karolin Trautmann-Grill¹, Leo Ruhnke¹, Jan Moritz Middeke¹, Malte von Bonin¹, Gerhard Ehninger³⁰, Christian Thiede³¹, Martin Bornhäuser¹, Johannes Schetelig^{1

32}, Uwe Platzbecker³³

Affiliations

¹ Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Dresden, Germany.
² Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Aachen, Germany.
³ Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Aachen, Germany.
⁴ Department of Internal Medicine 3, Klinikum Chemnitz GmbH, Chemnitz, Germany.
⁵ Department of Hematology, University Hospital Essen, Essen, Germany.
⁶ Klinik für Innere Medizin 5, Klinikum Nürnberg, Paracelsus Medizinische Privatuniversität, Nuremberg, Germany.
⁷ Abteilung für Hämatologie, Onkologie und Palliativmedizin, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
⁸ Department of Oncology, Hematology and Palliative Care, Marien Hospital Düsseldorf, Düsseldorf, Germany.
⁹ Department of Medicine III, Hematology/Oncology, TUM University Hospital, Munich, Germany.
¹⁰ Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
¹¹ Outpatient Center for Urology and Oncology, Rostock, Germany.
¹² Department of Hematology, Oncology and Tumor Immunology, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
¹³ Diakonie Klinikum Schwäbisch-Hall, Innere Medizin III, Schwäbisch Hall, Germany.
¹⁴ Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, Germany.
¹⁵ Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
¹⁶ National Centre for Tumor Diseases (NCT), Heidelberg, Germany.
¹⁷ Department of Medicine II, Hematology/Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
¹⁸ German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.
¹⁹ Frankfurt Cancer Institute, Goethe University Frankfurt, Frankfurt, Germany.
²⁰ Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
²¹ St Bernward Krankenhaus, Medizinische Klinik II, Hildesheim, Germany.
²² Hematology/Oncology and Nephrology Clinic, Friedrich-Ebert-Hospital Neumünster, Neumünster, Germany.
²³ Gemeinschaftspraxis Hämato-Onkologie Pasing, Munich, Germany.
²⁴ Department of Hematology, Claraspital Basel, Basel, Switzerland.
²⁵ GOKOS GmbH, Dresden, Germany.
²⁶ Sozialstiftung Bamberg, Department of Internal Medicine V, Bamberg, Germany.
²⁷ Department of Medicine IV, Klinikum Bayreuth GmbH, Bayreuth, and Comprehensive Cancer Center Erlangen-EMN, Germany.
²⁸ MVZ für Blut- und Krebserkrankungen Potsdam, Potsdam, Germany.
²⁹ Klinik Hämatologie und Onkologie, St. Marien-Hospital Hamm, Hamm, Germany.
³⁰ AvenCell Europe GmbH Dresden, Dresden, Germany.
³¹ AgenDix GmbH, Dresden, Germany.
³² Clinical Trials Unit, DKMS Group, Dresden, Germany.
³³ University Hospital Dresden, TU Dresden, Dresden, Germany.

PMID: 41036595
DOI: 10.1002/ajh.70091

Clinical Trial

Hypomethylating Therapy With or Without Eltrombopag in Elderly Patients With Acute Myeloid Leukemia: Results From the Randomized, Placebo-Controlled Phase 2 DELTA Trial

Katja Sockel et al. Am J Hematol. 2025 Dec.

. 2025 Dec;100(12):2436-2441.

doi: 10.1002/ajh.70091. Epub 2025 Oct 2.

Authors

Affiliations

¹ Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Dresden, Germany.
² Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Aachen, Germany.
³ Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Aachen, Germany.
⁴ Department of Internal Medicine 3, Klinikum Chemnitz GmbH, Chemnitz, Germany.
⁵ Department of Hematology, University Hospital Essen, Essen, Germany.
⁶ Klinik für Innere Medizin 5, Klinikum Nürnberg, Paracelsus Medizinische Privatuniversität, Nuremberg, Germany.
⁷ Abteilung für Hämatologie, Onkologie und Palliativmedizin, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
⁸ Department of Oncology, Hematology and Palliative Care, Marien Hospital Düsseldorf, Düsseldorf, Germany.
⁹ Department of Medicine III, Hematology/Oncology, TUM University Hospital, Munich, Germany.
¹⁰ Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
¹¹ Outpatient Center for Urology and Oncology, Rostock, Germany.
¹² Department of Hematology, Oncology and Tumor Immunology, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
¹³ Diakonie Klinikum Schwäbisch-Hall, Innere Medizin III, Schwäbisch Hall, Germany.
¹⁴ Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, Germany.
¹⁵ Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
¹⁶ National Centre for Tumor Diseases (NCT), Heidelberg, Germany.
¹⁷ Department of Medicine II, Hematology/Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
¹⁸ German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.
¹⁹ Frankfurt Cancer Institute, Goethe University Frankfurt, Frankfurt, Germany.
²⁰ Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
²¹ St Bernward Krankenhaus, Medizinische Klinik II, Hildesheim, Germany.
²² Hematology/Oncology and Nephrology Clinic, Friedrich-Ebert-Hospital Neumünster, Neumünster, Germany.
²³ Gemeinschaftspraxis Hämato-Onkologie Pasing, Munich, Germany.
²⁴ Department of Hematology, Claraspital Basel, Basel, Switzerland.
²⁵ GOKOS GmbH, Dresden, Germany.
²⁶ Sozialstiftung Bamberg, Department of Internal Medicine V, Bamberg, Germany.
²⁷ Department of Medicine IV, Klinikum Bayreuth GmbH, Bayreuth, and Comprehensive Cancer Center Erlangen-EMN, Germany.
²⁸ MVZ für Blut- und Krebserkrankungen Potsdam, Potsdam, Germany.
²⁹ Klinik Hämatologie und Onkologie, St. Marien-Hospital Hamm, Hamm, Germany.
³⁰ AvenCell Europe GmbH Dresden, Dresden, Germany.
³¹ AgenDix GmbH, Dresden, Germany.
³² Clinical Trials Unit, DKMS Group, Dresden, Germany.
³³ University Hospital Dresden, TU Dresden, Dresden, Germany.

PMID: 41036595
DOI: 10.1002/ajh.70091

Abstract

Primary endpoint treatment-change-free survival (TCFS), defined as time from randomization to death or initiation of a new disease-modifying treatment in the phase 2 DELTA trial. AML, acute myeloid leukemia; EPAG, eltrombopag; HMA, hypomethylating agents; IC, intensive chemotherapy.

Keywords: DELTA; elderly AML; eltrombopag; hypomethylating therapy; thrombocytopenia.

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Hypomethylating Therapy With or Without Eltrombopag in Elderly Patients With Acute Myeloid Leukemia: Results From the Randomized, Placebo-Controlled Phase 2 DELTA Trial

Affiliations

Hypomethylating Therapy With or Without Eltrombopag in Elderly Patients With Acute Myeloid Leukemia: Results From the Randomized, Placebo-Controlled Phase 2 DELTA Trial

Authors

Affiliations

Abstract

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Medical